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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003799
Receipt No. R000004593
Scientific Title Effect of recombinant thrombomodulin (ART123) for sepsis with disseminated intravascular coagulation
Date of disclosure of the study information 2010/07/01
Last modified on 2017/05/03

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Basic information
Public title Effect of recombinant thrombomodulin (ART123) for sepsis with disseminated intravascular coagulation
Acronym Effect of rTM for sepsis with DIC
Scientific Title Effect of recombinant thrombomodulin (ART123) for sepsis with disseminated intravascular coagulation
Scientific Title:Acronym Effect of rTM for sepsis with DIC
Region
Japan

Condition
Condition severe sepsis, septic shock, sepsis with disseminated intravascular coagulation
Classification by specialty
Infectious disease Emergency medicine Intensive care medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Previous studies showed that recombinant thrombomodulin(rTM) may improve the outcome of sepsis induced multiple organ failure because of its anticoagulant and anti-inflammatory properties. We have performed a randomized controlled trial to assess whether rTM has the effect for sepsis induced multiple organ failure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 28-day mortality
hemorrhagic event
Key secondary outcomes 28-day ICU mortality
SOFA score
data of coagulation (platelet, PT-INR, fibrinogen, FDP, TAT, PIC, ATIII, protein C, protein S)
data of inflammation (CRP, procalcitonin, IL-1beta, IL-6, TNF-alfa, HMGB1)
resolution rate of JAAM DIC score
weaning rate of mechanical ventilator

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of recombinant thrombomodulin
Interventions/Control_2 administration of saline
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria svere sepsis and septic shock with acute DIC score more than 4 points
Key exclusion criteria hemorrhagic complication
pregnant
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro OTOMO
Organization Tokyo Medical and Dental University Medical Hospital
Division name Shock, Trauma, and Critical Care Center
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5102
Email otomo.accm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki SERA
Organization Tokyo Medical and Dental University Medical Hospital
Division name Shock, Trauma, and Critical Care Center
Zip code
Address 1-5-45Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5102
Homepage URL http://www.tmd.ac.jp/med/accm/
Email seraaccm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University Medical Hospital
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 Day

Related information
URL releasing protocol http://www.tmd.ac.jp/med/accm/
Publication of results Partially published

Result
URL related to results and publications http://www.tmd.ac.jp/med/accm/
Number of participants that the trial has enrolled
Results
As of December 30, 2014, there were 27 cases for intervention group and 28 cases for placebo group.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information One adverse event occurred among intervention group.

Management information
Registered date
2010 Year 06 Month 22 Day
Last modified on
2017 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004593

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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